BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFRAME EXTENSION-ADJUSTABLE

    MDR report key: 2829572 · Received November 13, 2012

    Report

    Report Number
    8030965-2012-01256
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 16, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE KNURLED LOCKING THUMB BOLT BROKE OFF. THE DEVICE SHOWS MARKS OF WEAR AND FREQUENT USE. THE BROKEN OFF THREADED PORTION OF THE LOCKING THUMB BOLT REMAINS BLOCKED INTO THE THREAD OF THE SYNFRAME DEVICE. THEREFORE THE BREAKAGE RELEVANT DIMENSIONS CAN NOT BE CHECKED ANYMORE. THE MANUFACTURING DOCUMENTS SHOW THAT THE CORRECT MATERIAL WAS USED AND THE DEVICE MET TO THE SPECIFICATIONS AT THE TIME OF MANUFACTURING IN MAY 2006. THE DEVICE IS MORE THAN 6 YEARS OLD AND SHOWS WEAR AND MARKS OF FREQUENT USE. THE REMAINING PORTION OF THE KNURLED LOCKING KNOB SHOWS THE TYPICAL SIGNS OF A FORCED RUPTURE DURING A MECHANICAL OVERLOADING SITUATION. NO DESIGN RELATED FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DURING AN ALIF SYNFRAME PROCEDURE AT L3-L4, L4-L5, AS THE SURGEON WAS FINAL TIGHTENING THE THUMB BOLT TO SECURE THE RING EXTERNAL TO THE BODY, THE KNOB ON THE SYNFRAME EXTENSION THUMB BOLT BROKE OFF. THE SURGEON DID NOT ELECT TO USE ANOTHER INSTRUMENT TO FINISH THE PROCEDURE. THE PIECE WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH NO FURTHER INCIDENT. THE PATIENT WAS REPORTEDLY RECOVERING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNFRAME EXTENSION-ADJUSTABLE SYNFRAME EXTENSION-ADJUSTABLE LXH SYNTHES GMBH 1479767

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR